Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0496-2018 — Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technolo

U.S. FDA — Device Enforcement · United States · 2017-10-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0496-2018
Date of alert: 2017-10-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Edwards Lifesciences, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00690103197006

Reported risk: Pre-procedural issues related to software defects

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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